Some tainted
supplements (also known as fake supplements), may be endorsed by fake
advertising, fake doctors, fake testimonials, fake literature and fake product
labels. At issue are products marketed
as harmless dietary supplements for arthritis and other conditions that contain
hidden or deceptively labeled ingredients, such as the active ingredients in
government-approved drugs or closely related drugs, as well as other compounds,
such as synthetic steroids that don’t qualify as natural ingredients.1

Dietary supplements have caused serious adverse reports associated with their consumption, including strokes, artery blockage in the lungs, kidney failure, acute liver injury, and death. An estimated 23,000 emergency department visits in the United States every year are attributed to adverse events related to supplements, according to research reported October 2015 in the New England Journal of Medicine (NEJM).2

Most commonly, the tainted products marketed as dietary supplements are for losing weight, sexual enhancement, or muscle building. Tainted supplements, however, are promoted for nearly every health condition of record, including osteoarthritis, gout, rheumatoid arthritis, cancer, diabetes, heart disease and many others.

Consumers responsible for discovering tainted products

The cGMP manufacturing rules have been lampooned by health experts and industry watchdogs as "too weak" and "too lax". Under these regulations, the consumer is mainly responsible
for detecting the possibility of tainted supplements. The FDA depends on reports of adverse health
reactions to help identify potentially harmful products. Once the FDA confirms a tainted supplement,
it initiates enforcement measures with the manufacturer, including recalls.

The following
disclaimer appears on the FDA webpage, Dietary
Supplements—How to Report a Problem:

“FDA
does not approve dietary supplement products before they are sold to
the public. Therefore, it is
particularly important for consumers, health professionals, and industry
members to report serious health-related reactions or illnesses (also known as
adverse events) to FDA, so we can take action to protect thepublic
from unsafe products.”3

On its webpage, Tainted Products Marketed as Dietary Supplements, the
FDA warns the public of tainted supplements and publishes the following disclaimer::

“This list only includes a small fraction of the potentially hazardous products with hidden ingredients marketed to
consumers on the internet and in retail establishments.FDA is
unable to test and identify all products marketed as dietary supplements on
the market that have potentially harmful hidden ingredients. Even if a product is not included in this
list, consumers should exercise caution before using certain products.”4

FDA warns consumers after it discovers or confirms tainted supplements

The FDA also maintains a Tainted Arthritis Pain Productspage with a
partial list of tainted supplements promoted for arthritis.5

In addition, FDA publishes warnings for fake supplements. For example, an FDA Public Notification was
issued October 30, 2017 for Linsen Double
Caulis Plus, a tainted supplement
containing hidden drug ingredients. The notification advises consumers not to
purchase or use Linsen Double Caulis Plus,
a product promoted on various websites for joint pain, gout, and back
pain. The agency’s laboratory analysis
confirmed the dietary supplement contains dexamethasone, a pharmaceutical
corticosteroid commonly used in short-term situations to treat inflammatory
conditions (like rheumatoid arthritis) and may not be appropriate for all
patient cases.6

Whenever the FDA discovers undeclared drugs in a supplement, it changes the dietary supplement classification to that of "an unapproved new drug". An automatic recall is initiated. There have been many supplement recalls of products promoted for arthritis pain and joint discomfort that contain illegal hidden drugs.

Tainted supplements can slip through cracks of weakness in the manufacturing practices rules. The cGMP has no standardized raw materials testing requirement. FDA facilities inspections find some supplement companies conduct only superficial testing or none at all.

Dietary supplement manufacturers are not only allowed to make products without FDA approval, but also market them without the FDA ever seeing the finished product. In addition, manufacturers do not need to prove the effectiveness of their products. No clinical studies are required. Under the Dietary Supplement Health & Education Act (DSHEA) of 1994, supplements are in a food category, not drugs.

The FDA has primary responsibility for claims on dietary
supplement labeling, including packaging, inserts and other promotional
materials distributed at the point of sale. The Federal Trade Commission (FTC) has primary responsibility
for claims in advertising, including print and broadcast ads, infomercials,
catalogs and similar direct marketing materials.7

On October 5, 2016 the FTC announced a $150 million judgment against a liquid glucosamine and chondroitin supplement, Supple, which the sellers agreed made false claims about the product. The company had inadequate evidence to support advertising claims the supplement was scientifically proven to provide complete relief from chronic and severe joint pain caused by arthritis and fibromyalgia.8

“Companies need solid scientific evidence to back up the health claims they make,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “Consumers should not have to take it on faith that products claiming to provide pain relief will live up to their billing.”

The sellers also sponsored an infomercial with one company principal acting as a fake medical show-style host and falsely represented herself as an independent, impartial medical expert. Another company principal, who created the product, falsely represented himself as a third-party testimonial guest. The infomercial did not disclose the fact the two were married.

From 2011 to 2015 the defendants took in more than $150.6 million from nationwide sales of the supplement, which was marketed through infomercials, social media and other internet marketing’ radio ads, brochures, and in-person pitches at community events. Settlement includes $150 million judgment, suspended due to the financial status of the company.

FDA finds some tainted supplements during
facilities inspections

Some tainted products are discovered during
FDA facilities inspections of dietary supplement manufacturers. FDA inspects only a fraction of more than
15,000 domestic and international makers of supplements sold in the United
States due to limited resources, according to a 2015 study in the journal Drug Testing and Analysis.10

The study pointed to poor compliance of manufacturing regulations for dietary supplements as the agency finds significant deficiencies in about two-thirds of the inspections it conducts, with most facilities cited for multiple, serious violations. Commonly identified manufacturing shortcomings include failure to verify that a finished batch of supplements meets product specifications such as identity, purity, strength, composition, and failure to verify the identity of a dietary ingredient prior to use through at least one appropriate test or examination.10

The FDA inspected a total of 2,137 unique dietary supplement facilities (including 184 foreign facilities) between January 2010 and September 2017, according to Merle Zimmermann, PhD, American Herbal Products Association (AHPA), in an article published January 5, 2018 in Nutraceuticals World. The latest data shows that FDA inspected 610 facilities in fiscal year 2017, an increase over previous years, with less violations.11

Most experts believe it’s too
soon to project the affect the Trump Administration may have with the FDA’s
enforcement ability with dietary supplements.
Many of his key appointments were stalled in Congress during Trump’s
first year in office, making a meaningful assessment difficult. The Senate did
not confirm Scott Gottlieb. M.D. as the new Commissioner of the FDA until May
9, 2017.

President Trump has
promised to ease government regulations.
He has not hesitated to call out the pharmaceutical industry over high
drug prices. Have the FDA dietary
supplement inspectors looked the other way on some of the lesser
violations? No one knows for sure. For FY 2017, there were less Form 483
non-compliances issued than previous years.
Was this by edict? Fiscal year
2018 should provide better insight if figures become available..

If dietary supplement
manufacturers are held to even lesser regulatory standards than during the
Obama Administration, will the industry see an increase in tainted
supplements? Only time will tell. Whatever the answers, the American public
will likely continue to serve as guinea pigs when consuming harmful
supplements.

FTC website says hundreds of tainted supplements are on market

The FTC reports on its Dietary Supplements webpage that in the last few years the FDA has
discovered hundreds of tainted supplements containing drugs or other chemicals.9

Some tainted supplements are for products that promote
relief for osteoarthritis, rheumatoid arthritis, gout and other health
conditions, but particularly in products for weight loss, sexual enhancement,
or bodybuilding.

Tainted supplements often contain hidden ingredients,
not listed on the label, but that could cause serious side effects or interact
in dangerous ways with medicines or other supplements.

To recognize tainted supplements, the FTC says look
for the following:

Products claiming to be alternatives
to FDA-approved drugs or have effects similar to prescription drugs.

Products claiming to be legal alternatives to anabolic steroids.

Marketing materials primarily in a foreign language.

Promises of rapid effects or results..

No fear of tainted supplements with our recommended industry leader

Are your dietary supplements for osteoarthritis, gout or
rheumatoid arthritis the best that money can buy?

Are they organic; or as our
recommended company promises, beyond organic?

Are their ingredients tested for contaminants?

Are they safe? Are they
supported by clinical studies?

Are they tested for efficacy prior to marketing
to confirm effectiveness in the human body?

Are the contents accurately listed on the product label?

Surprisingly, for a large majority of dietary
supplements on the market, the answer to many of these questions is a
resounding NO.

We recommend one manufacturer from personal use that answers YES to each question, the #1 natural nutrition company in the U.S. For arthritis relief, their “pain trio” of joint and muscle pain relief products are extremely safe, tested and effective.

Remarkably different from other supplement companies, they operate more like a pharmaceutical manufacturer. They won’t produce tainted supplements because the quality and science behind their products are unmatched in the industry.

They far exceed the cGMP’s for purity. They’re the only supplement company we’ve heard of that clinically tests all their nutritional products for efficacy. In business since 1956, this California-based leader is the gold standard supplement company. There;s no need to fear illegal supplements with them!

Natural Supplements. Glucosamine, boswellia, GLA, Lecithin, Vit-E and the best omega-3 fish oil are among dietary supplements that provide alternative treatment to painkilling drugs for arthritis with minimal side effects. Click here for more information

Health statements have not been evaluated by the Food & Drug Administration.
This site is not intended to diagnose, treat, cure, or prevent any disease.
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